Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

FZT — Predicate Candidate Screening

52 FDA 510(k) clearances under this product code; the 50 most recent screened below.

20 daysmedian FDA review time
29 days90th percentile
52clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K112400SMARTSHEARSNuscience Consulting and Management Group, LLC2011-09-12240
K890818AUTO SUTURE DISPOSABLE SURGICAL TROCAR*United States Surgical, A Division of Tyco Healthc1989-05-04760
K872990MICRINS SURGICAL SCISSORMicrins Surgical, Inc.1987-08-17170
K841741SINGLE HAIR TRANSPLANT GRAFTParis Products, Inc.1984-07-23910
K841247SPC DISPOSABLE CUTTERSurgical Products Corp.1984-05-02420
K822448SCISSORS, VARIOUSJ. Sklar Mfg. Co., Inc.1982-09-14290
K821632SURGICAL SCISSORS, SET OF 3Fred Sammons, Inc.1982-06-24210
K821355CONPHAR LITTAUER SCISSORSConphar, Inc.1982-05-27210
K821352CONPHAR IRIS SCISSORSConphar, Inc.1982-05-27220
K821361CONPHAR TONSIL SCISSORSConphar, Inc.1982-05-27200
K821350CONPHAR WIRE CUTTING SCISSORSConphar, Inc.1982-05-27220
K821351CONPHAR DISSECTING SCISSORSConphar, Inc.1982-05-27220
K821124SCISSORS 6 & 1/2 SHARP/BLUNTConphar, Inc.1982-05-07170
K821111CONPHAR SCISSORS 4&AHALF SHARPSHARPConphar, Inc.1982-05-07170
K821125OPERATING SCISSORS 5 &1/2 SHARP BLUNT&Conphar, Inc.1982-05-07170
K821119OPERATING SCISSORS 4 & 1/2 BLUNT/BLUNTConphar, Inc.1982-05-07170
K821122OPERATING 5 & 1/2 STRAIGH SHARP/BLUNTConphar, Inc.1982-05-07170
K821116LISTER BANDAGE SCISSORS 5 & 1/2Conphar, Inc.1982-05-07170
K821126LISTER BANDAGE SCISSORS 3 & 1/2Conphar, Inc.1982-05-07170
K821113OPERATING SCISSORS 5&1/2 CURVED SHARPConphar, Inc.1982-05-07170
K821115SCISSORS CURVED 4 & 1/2 SHARPConphar, Inc.1982-05-07170
K821121SCISSORS 5 & 1/2STRAIGHT BLUNT/BLUNTConphar, Inc.1982-05-07170
K821112CONPHAR SCISSORS 4&1/2 SHARP BLUNTConphar, Inc.1982-05-07170
K821120OPERATING SCISSORS CURVED 4 & 1/2 BLUNTConphar, Inc.1982-05-07170
K821114OPERATING SCISSORS CURVED 6 & 1/2 SHARPConphar, Inc.1982-05-07170
K821117SCISSORS STRAIGHT 5&1/2SHARPConphar, Inc.1982-05-07170
K821118BANDAGE SCISSORS 4 & 1/2Conphar, Inc.1982-05-07170
K821123LISTER BANDAGE SCISSORS 7 & 1/2Conphar, Inc.1982-05-07170
K820170MED-CARE EMERGENCY SHEARSMedcare Products1982-02-05150
K801746SUTURE REMOVAL PAKDevco Medical Industries, Inc.1980-08-20230
K800103SURGICAL STITCH CUTTERMacon & Co., Inc.1980-01-28120
K791984SCISSOR'S #'S 2294,2262,2263Edward Weck, Inc.1979-10-17220
K791741FLOOR LINE INSTRUMENTSEdward Weck, Inc.1979-10-04240
K791742BROOKS GALL BLADDER SCISSORS (SURG)Edward Weck, Inc.1979-10-04240
K791734SURGICAL INSTRUMENTS HEIFETZ DIGITATEEdward Weck, Inc.1979-09-12120
K790684COLOR CODING OF SURGICAL INSTRUMENTSSara Dan, Inc.1979-05-18370
K790491ITIMIZED INSTRUMENTSE.M. Adams1979-04-04270
K780574SUTURE CUTTERLaschal Instrument Corp.1978-07-17980
K780575LASCHAL SCISSORLaschal Instrument Corp.1978-04-1880
K780152FACELIFT SCISSORSEdward Weck, Inc.1978-02-0230
K772301LAPAROSCOPY DRAPE, BOUNDARYProcter & Gamble Mfg. Co.1977-12-2060
K771806THOREK SCISSORS 7 1/4 & 10J. Sklar Mfg. Co., Inc.1977-10-04110
K771743SURG. SCISSORS FOR CUTTING TISSUEDepuy, Inc.1977-09-26110
K770541SCISSORS, SURGICAL, 12.5,14,16 & 18 CM.Sea-Pac Trading Corp.1977-04-15250
K770544SCISSORS, BANDAGE, 15,18,20CM., ANGULARSea-Pac Trading Corp.1977-04-15250
K770542SCISSORS, MAYO _TYLE, 14,16,18,20,22 CM.Sea-Pac Trading Corp.1977-04-15250
K770543SCISSORS, SURGICAL, ANGULAR, 14 CM.Sea-Pac Trading Corp.1977-04-15250
K770305CUTTER, P607 BONEDentronix, Inc.1977-03-09210
K770302CUTTER, P606 BONEDentronix, Inc.1977-03-09210
K770304CUTTER, P605 GENERAL PURPOSEDentronix, Inc.1977-03-09210

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda